Assessing Bone Fracture Healing Effect of Prunus Dulcis (Almonds) - A Randomized Controlled Trial

What this Trial Is About

Researchers are investigating the effects of sweet almonds on healing femur and tibia shaft fractures compared to routine vitamin D3 supplements. This study addresses the need for an affordable and safe alternative to bone-strengthening drugs, which often cause side effects and are costly. The trial focuses on patients with vitamin D insufficiency or deficiency, assessing the potential of almonds to improve bone healing and vitamin D levels in the blood. The trial is a single-center, open-label, crossover randomized controlled study involving 136 participants aged 18 to 55 with trauma-related femur and tibia shaft fractures. Participants are divided into two groups based on their vitamin D levels and receive treatments including daily whole almonds (5 grams/day) and weekly oral vitamin D3 (200,000 units) in various sequences with washout periods. Group 1 includes vitamin D insufficient patients receiving almonds and vitamin D3 in a crossover design, while Group 2 includes vitamin D deficient patients receiving vitamin D3 alone, almonds alone, or a combination followed by crossover treatments. Participants undergo follow-up visits at 4 and 13 weeks post-treatment, where fracture healing is monitored through routine X-rays and Radiological Union Score for Tibial fractures (RUST). Safety is closely assessed, with adverse events recorded and managed according to international guidelines. The study also tracks treatment adherence with daily diaries and compares costs and changes in blood vitamin D levels. Patients may withdraw at any time without losing their rights, and the study will be completed within 24 months including a close-out period.

Assessing Bone Fracture Healing Effect of Almonds